Quoin Pharmaceuticals, Ltd.

Quoin Pharmaceuticals Ltd. has entered into a sales agreement with Leerink Partners LLC, enabling the company to sell its American Depositary Shares (ADSs) through 'at the market offerings'. Leerink Partners will act as the sales agent, receiving a 3.0% commission on gross sale proceeds. The agreement allows for the suspension or termination of the offering by either party. The ADSs will be offered under the company's effective Registration Statement on Form S-3.

Quoin Pharmaceuticals announced it will release its second-quarter 2026 financial results and provide a corporate update before market open on Friday, August 14, 2026. The announcement will include an operational update highlighting key achievements and recent accomplishments from the quarter. The company is a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases.

Quoin Pharmaceuticals, Ltd. announced its 2026 Annual General Meeting of Shareholders (AGM) to be held on August 20, 2026. Shareholders will vote on several key proposals, including the election of seven directors, an advisory vote on executive compensation, and changes to non-employee director compensation and 401(k) matching contributions. Additionally, the appointment of CBIZ CPAs P.C. as the independent auditor will be considered. The record date for voting eligibility is July 15, 2026.

Quoin Pharmaceuticals announced that the USPTO has issued a Notice of Allowance for a patent application titled "Combination Treatment for Netherton Syndrome." This patent supports the intellectual property strategy for QRX003, its investigational treatment for Netherton Syndrome, a rare genetic skin disease with no approved treatments. The allowed claims cover a method of treating the condition using a topical serine protease inhibitor and an anti-inflammatory agent, including patients with SPINK5 mutations. This development strengthens the long-term value of the QRX003 program, which has multiple regulatory designations and is progressing towards a potential NDA filing in 2027.

Quoin Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has conditionally approved QYLEKI™ as the proposed brand name for QRX003, its investigational product for Netherton Syndrome. This marks a significant milestone as the company progresses towards delivering the first approved treatment for the rare disease. QRX003 already holds Orphan Drug, Fast Track, and Rare Pediatric Disease Designations. The pivotal Phase 3 study is expected to begin in the second half of 2026, with a potential NDA filing in 2027.

Quoin Pharmaceuticals announced the establishment of a wholly-owned subsidiary in Japan to directly commercialize QRX003 for Netherton Syndrome, if approved. This move follows the recent grant of Orphan Drug Designation for QRX003 by Japan's Ministry of Health, Labour and Welfare, reinforcing Quoin's long-term commercial strategy in one of its three core markets. The new local presence will facilitate direct engagement with Japanese regulators, clinicians, and patient advocacy groups as the company builds its commercial infrastructure ahead of a potential launch. QRX003 has now secured Orphan Drug Designation in the United States, the European Union, and Japan, providing significant development and commercial incentives.

Quoin Pharmaceuticals announced positive clinical results from its pediatric Netherton Syndrome (NS) Compassionate Use program for QRX003. Four of six enrolled patients, all under 10 years old, showed 'Improved' or 'Significantly Improved' status across key clinical endpoints. Notably, one patient achieved a full 5-grade improvement in IGA and remains clear at 15 months, while a 6-month-old infant saw significant reduction in emollient use and restored neutrophil levels after just 3 weeks. No treatment-related adverse events have been reported, and additional patients are enrolling.

Quoin Pharmaceuticals announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug Designation to its QRX003 lotion (4%) for the treatment of Netherton Syndrome. This designation offers significant development incentives in Japan, including up to 10 years of market exclusivity upon approval. The company is advancing QRX003, with a pivotal Phase 3 study planned for the second half of 2026 and a potential NDA filing in 2027.

Quoin Pharmaceuticals announced that Japan's Ministry of Health, Labour and Welfare (MHLW) granted Orphan Drug Designation to QRX003 for Netherton Syndrome. This designation provides significant development incentives, including up to 10 years of market exclusivity upon approval in Japan. This adds to previous Orphan Drug, Pediatric Rare Disease, and Fast Track Designations from the U.S. FDA and Orphan Drug Designation from the European Medicines Agency. Japan is a strategically important market where Quoin plans to self-commercialize QRX003, with a pivotal Phase 3 study expected to start in the second half of 2026.

Quoin Pharmaceuticals announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for QRX003 to treat Peeling Skin Syndrome (PSS), marking the first-ever IND for this disease. The company plans to initiate a Phase 2 clinical study in the second half of 2026, pending FDA review. This submission is supported by positive initial clinical data from an investigator-led pediatric study, where QRX003 showed significant improvements in skin, sleep, and quality of life over 15 months with no adverse events. This is the second indication for QRX003, in addition to Netherton Syndrome, highlighting its versatility.